In July 2012 the new Pharmacovigilance legislation came into effect with a focus on robust systems for public health that encourage efficiency and transparency. The EMA Executive Director Guido Rasi explained that:
As the European Medicines Agency finalizes the first set of Good Pharmacovigilance Practices are you ready for the Transition to the New PV Legislation?
With just over a week to go before the Article 57(2) requirements for population of the eXtended Eudravigilance Medicinal Product Dictionary (XEVMPD) become mandatory, the European Medicines Agency (EMA) has today published an updated version of the ‘eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs)’ document.
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